结合热分离猪耳表皮和垂直扩散细胞的药物渗透评估的逐步方案

IF 0.8 4区 工程技术 Q4 ENGINEERING, CHEMICAL
I. Pantelić, T. Ilić, B. Marković, Sanela M. Savic, M. Lukić, S. Savić
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引用次数: 7

摘要

在对局部半固体药物体外皮肤性能最合适的评估方法缺乏官方共识的几十年后,美国药典(USP 39)最终提出了三种类型的测试设备;然而,所有这些都提供了使用惰性合成膜的药物释放数据。考虑到需要一种结构更类似于人类皮肤的易于获得的膜,本文提供了一种使用热分离猪耳表皮和改良Franz扩散细胞的药物渗透评估方法的详细方案。确定了对结果可变性至关重要的阶段(例如膜制备),并优化了工艺参数。以四种以乙酰氯芬酸为模型药物的乳膏样品为实验对象,对该方法的适用性进行了验证。样品组成以这样一种方式设计,以提供“大”变化(主稳定剂的变化:天然来源与合成乳化剂)和相对“小”变化(共溶剂变化:无/异丙醇/甘油)。开发的方案是一种简单可靠的体外试验,用于评估药物进入/通过皮肤的速度和程度。此外,该方案可以常规应用,甚至在一般装备的实验室在配方开发或初步生物等效性评估的通用局部半固体。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A stepwise protocol for drug permeation assessment that combines heat-separated porcine ear epidermis and vertical diffusion cells
After decades long absence of an official consensus on the most appropriate evaluation method for in vitro skin performance of topical semisolid drugs, United States Pharmacopoeia (USP 39) finally suggested three types of testing equipment; however, all these provide data on drug release using inert synthetic membranes. Considering the need for a readily available membrane that would be more structurally similar to human skin, this paper provides a detailed protocol of a method for drug permeation assessment that uses heat-separated porcine ear epidermis and modified Franz diffusion cells. Phases that were shown to be critical for variability of the results are identified ( e.g. membrane preparation), and process parameters optimized. Applicability of the method was tested on four cream samples loaded with aceclofenac as a model drug. Sample compositions were designed in such a way to provide „large“ variations (variation of the main stabilizer: natural-origin versus synthetic emulsifier) and relatively „minor“ variations (co-solvent variation: none/isopropanol/glycerol). The developed protocol is a straightforward and reliable in vitro test for the evaluation of rate and extent of drug delivery into/through the skin. Moreover, this protocol may be routinely applied even in averagely equipped laboratories during formulation development or preliminary bioequivalence assessment of generic topical semisolids.
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来源期刊
Hemijska Industrija
Hemijska Industrija 工程技术-工程:化工
CiteScore
1.60
自引率
11.10%
发文量
12
审稿时长
6-12 weeks
期刊介绍: The Journal Hemijska industrija (abbreviation Hem. Ind.) is publishing papers in the field of Chemical Engineering (Transport phenomena; Process Modeling, Simulation and Optimization; Thermodynamics; Separation Processes; Reactor Engineering; Electrochemical Engineering; Petrochemical Engineering), Biochemical Engineering (Bioreactors; Protein Engineering; Kinetics of Bioprocesses), Engineering of Materials (Polymers; Metal materials; Non-metal materials; Biomaterials), Environmental Engineeringand Applied Chemistry. The journal is published bimonthly by the Association of Chemical Engineers of Serbia (a member of EFCE - European Federation of Chemical Engineering). In addition to professional articles of importance to industry, scientific research papers are published, not only from our country but from all over the world. It also contains topics such as business news, science and technology news, information on new apparatus and equipment, and articles on environmental protection.
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